CAPA Procedure - ISO 13485

ISO 13485:2016 QMS Template - CAPA (Corrective & Preventive Action) Procedure

Improve your Quality Management System with our ISO 13485:2016 compliant CAPA Procedure template. The professionals at Patient Guard designed this template to meet the specific requirements of the ISO 13485:2016 standard.

Why Choose Our Template?

• Expertly Designed: Our Quality Assurance and Regulatory Affairs specialists created this template to ensure full compliance with ISO 13485:2016 standards.
• Easy Customization: The template is fully editable in Microsoft Word, allowing you to modify it to suit your business needs and branding.
• Compliance Assurance: Using our template helps you maintain effective corrective and preventive action procedures. This supports strong quality management as required by ISO 13485:2016.

What is Corrective Action?

Corrective Action involves steps to reduce or eliminate the cause of a reported non-conformity or inefficiency in your Quality Management System. The goal is to prevent the issue from happening again by updating procedures.

What is Preventive Action?

Preventive Action involves steps to reduce or eliminate the chance of a non-conformity or inefficiency before it happens. It is based on risk analysis, GAP assessment, or similar processes that identify potential issues in your Quality Management System.

How Will the CAPA Procedure Help My Organization?

This template helps your organization by:

• Root Cause Analysis: Outlining steps to analyze and investigate the root cause of non-conformities.
• Action Identification: Identifying actions needed to correct and prevent issues related to products, processes, or the quality management system.
• Effectiveness Verification: Verifying and validating that the CAPA was effective and did not negatively affect the finished product.

Why Choose Patient Guard?

Moreover, you can stay ahead with Patient Guard’s consultancy services, which offer affordable solutions for your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to share feedback, you can easily email us at qmsregs@patientguard.com.

In addition, visit our blog for the latest updates on regulatory and quality assurance news. So, take the next step in improving your Quality Management System with Patient Guard.

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Explore More Templates

Finally, don’t forget to visit QMSREGS.com for more templates that might interest you.